Self-regulation of autologous cell therapies

March 11, 2014

Med J Aust 2014; 200 (4): 196.

doi:10.5694/mja13.11043

Authors: Bernard E Tuch, Dominic M Wall

A first step for a virtually unregulated industry

Autologous cell therapies are being used privately by increasing numbers of clinicians to treat a number of disorders including rheumatological conditions, sports injuries, strokes, Parkinson disease and multiple sclerosis.1 Sources of cells include stromal vascular fractions obtained during liposuction which contain mesenchymal stem cells,2 as well as platelet rich plasma obtained from peripheral blood.3

In Australia, prospective authorisation of autologous cell therapies by the Therapeutic Goods Administration (TGA) is often not required. The current regulations contain exceptionally broad exemptions permitting clinicians to treat their patients with autologous cells without restrictions either on the extent of manipulation (excluding genetic manipulation) or the intended final use of the cells. The TGA’s expectation is that the Australian Health Practitioner Regulation Agency (AHPRA) would regulate these clinical practices. In contrast, the United States’ Food and Drug Administration (FDA) requires minimum standards for manufacturing autologous cells, and more than minimal manipulation of cells requires both manufacturing and product approvals.

Some Australian companies have become concerned about the lack of oversight of the safety, efficacy and ethics of cell-based…